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SuicideNCT02576834

Suicide Prevention Among Substance Abusing Homeless Youth

A study testing Cognitive Therapy for Suicide Prevention and Services as Usual in people with Suicide, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The literature is characterized by a dearth of information on interventions for homeless youth, and no suicide prevention intervention has been tested with these youth. Such focus is critical as suicide is the leading cause of death among homeless youth. Read more about this study

Who is it for?
Ages 18 to 24 yearsHealthy volunteers can take part
Conditions the study is for
Suicide
What is being tested?
Cognitive Therapy for Suicide Prevention and Services as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteUnited States
Study dates
Jul 2015to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18-24
  • meet McKinney Vento definition for homelessness.
  • Youth reports at least one episode of severe suicide ideation in the past 90 days.

Who cannot join

  • Evidence of unremitted psychosis or other condition which would impair youth's ability to understand and participate in the research.
  • Youth requires psychiatric hospitalization.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The Ohio State University Department of Human Development and Family Science

    Columbus, Ohio, 43210

Other trials in United States

About this study

The literature is characterized by a dearth of information on interventions for homeless youth, and no suicide prevention intervention has been tested with these youth. Such focus is critical as suicide is the leading cause of death among homeless youth. Therefore, this study seeks to address this gap in the research literature with the goal to identify an effective strategy to intervene in suicide ideation in this population.

Read the detailed description

While research on homeless youth is increasing, there is a dearth of information regarding effective interventions for these youth. This is of significant concern because studies indicate that 70-95% report problem alcohol or drug use and 66% to 89% of homeless youth have a mental health disorder. Suicide is the leading cause of death with up to 68% of youth reporting a lifetime suicide attempt. Among those who have attempted, an average of 6.2 attempts is reported. In addition, lifetime suicide ideation rates have ranged from 14% to 66.5%. Some predictors of suicide among homeless youth have been identified. These include substance use, childhood physical and sexual abuse, victimization experiences while living on the streets, and psychological functioning, including depression, hopelessness, distress tolerance, impulse control, social support, and problem solving. This study uses general cognitive theory, complemented with concepts from two suicide specific theoretical models, to guide our intervention and conceptual change model. Consonant with the pilot R34 announcement, this study's goal is to pilot test an intervention that has previously demonstrated feasibility and promise with adolescent suicide attempters and efficacy with a low-income sample of adults, "The Cognitive Therapy Intervention for Suicide Attempters." One-hundred fifty homeless youth with recent severe suicide ideation will be randomly assigned to the experimental cognitive therapy for suicide prevention (CTSP) + services as usual (SAU) (n=75) or to SAU alone (n=75). SAU includes those services normally offered through a local drop-in center. Follow-up assessments will be conducted at 3, 6, and 9-months post-baseline. It is hypothesized that youth receiving CTSP+SAU will show greater reductions in suicide ideation (primary outcome), substance use and depressive symptoms (secondary outcomes) over time compared to SAU alone. Furthermore, theoretically-derived mediators will be tested to shed light on mechanisms associated with change. The data from this study will be used to determine the initial efficacy of this promising intervention, and determine whether findings warrant a broader scale effectiveness trial. Ultimately, attention towards reducing suicide risk among these youth has the potential to reduce premature mortality, hospitalization and loss of human capital in a very high risk population of youth.

Conditions
Suicide
Being tested
Cognitive Therapy for Suicide Prevention, Services as Usual
Medical subject headings
Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Therapy for Suicide PreventionBehavioural

    Also called CTSP

    10 sessions of cognitive therapy for suicide prevention provided, along with optional 9 booster sessions + SAU

  • Services as UsualOther

    Also called SAU

    Services as usually provided in the community

Study groups in NCT02576834
Study groupRoleWhat they receive
CTSP + SAUExperimental10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with optional 9 booster sessions + SAU
Receives: Behavioral: Cognitive Therapy for Suicide Prevention; Other: Services as Usual
Services as Usual (SAU)Otherclient receives services they would normally receive within the community
Receives: Other: Services as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in suicide ideation

    suicide ideation assessed at baseline, 3, 6 and 9 months post-baseline using self-report measures

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionDec 2017
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02576834
Sponsor's protocol ID
2014B0532
Other IDs
R34DA037845
Status last verified
Aug 2019
First submitted
10 Oct 2015
Last updated
3 Sep 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Therapy for Suicide Prevention and Services as Usual in people with Suicide, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in suicide ideation (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.

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